Medical technology manufacturer Pristine Surgical has secured 510(k) clearance for its Summit 4K single-use surgical arthroscope from the US Food and Drug Administration (FDA).
Summit has been designed to improve the safety, consistency and efficiency of arthroscopic procedures.
It combines a 4K single-use surgical arthroscope with Pristine Connect, a cloud-based software, to provide a high-definition image with a new device every time.
The company stated that Summit is simple to set up and completely sterile, ensuring safety for patients and staff.
Its automated inventory management improves both workflow and predictability.
Pristine Surgical chief medical officer Dr Stephen Snyder said: “The Summit single-use arthroscope represents a new paradigm in arthroscopy, improving a procedure that hasn’t changed much in my 42 years of practice and beyond.
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“We’re removing the well-known barriers of legacy, reusable systems that eventually become obsolete by offering a new 4K single-use scope that improves safety and reliability while decreasing room turnover time and the cost of arthroscopic treatment.”
The new single-use arthroscope has been developed to address the challenges faced with conventional surgical visualisation, which features reusable arthroscopes that are difficult to maintain and is said to be expensive and complex.
Pristine intends to introduce the new arthroscope during the first quarter of the year.
It plans to offer the arthroscope through a predictable and transparent subscription pricing model with an automated re-ordering system.
Additionally, it intends to offer recycling options through sustainability partnerships.
Pristine Surgical CEO Bryan Lord said: “Summit simplifies arthroscopic procedures, offering a fully integrated single-use scope with 4K resolution that’s one-of-a-kind.
“Our FDA clearance is a significant milestone for the company. More importantly, it means that we can now begin offering the benefits of these single-use devices to surgeons and staff, and bring our single-use, cloud-based platform to more than 125 million endoscopy patients treated worldwide each year.”